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FDA Seeks Feedback on Premarket Submission Progress Tracker

The U.S. Food and Drug Administration (FDA) is requesting input on a planned web-based tracking system that would allow medical device manufacturers to view the progress of their premarket submissions through the FDA’s review process.

In a posting to the agency’s website in early September, the FDA says that the planned tracker system would provide manufacturers with “near real-time submission status,” regarding their submissions. At a minimum, the FDA is seeking information in connection with the following questions;

  • What information would be most useful to have in tracking a premarket submission under review?
  • What information or features would address a challenge that manufacturers have experienced or are experiencing with up-to-date information on the status of the FDA review process?
  • What additional communications methods could be useful to receive information on the progress of a premarket submission?

Anonymous comments can be submitted to the FDA by sending an email to PremarketProgressTracker@fda.hhs.gov. The deadline for the submission of comments on the planned progress tracker is October 8, 2020.

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Additional details on the FDA’s premarket progress tracker are available at the FDA website.

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